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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004460
Receipt No. R000005344
Scientific Title Neoadjuvant chemotherapy and radiotherapy for operable breast cancer
Date of disclosure of the study information 2010/10/27
Last modified on 2017/05/08

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Basic information
Public title Neoadjuvant chemotherapy and radiotherapy for operable breast cancer
Acronym Neo CR
Scientific Title Neoadjuvant chemotherapy and radiotherapy for operable breast cancer
Scientific Title:Acronym Neo CR
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of anthracycline, paclitaxel and radiotherapy in the neoadjuvant setting for operable breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes pathological complete response rate
Key secondary outcomes clinical response rate
disease free survival
rate of breast-conserving surgery
adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 neoadjuvant chemotherapy and radiotherapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) biopsy-proven invasive breast cancer
2) TNM classification: T2-T4, N0-2, M0
3) HER2-negative tumor
4) PS (ECOG): 0 or 1
5) Normal bone marrow, liver and renal function
6) Patients who have never received any treatment for breast cancer
7) Written informed consent is obtained
Key exclusion criteria 1) past history of any invasive malignancy within the previous 5 years
2) past history of breast cancer or synchronous bilateral breast cancer
3) past history of radiotherapy for ipsilateral breast
4) Suspicious of allergy for radiotherapy
5) Suspicious of allergy for paclitaxel, 5FU, epirubicin or cyclophosphamide
7) Patients during uncontrollable diabetes or psychologic disorder
8) Patients who have grade3-4 neuropathy
9) Pregnant or breast-feeding
10) Any reason the physician believes that the patient is not appropriate to participate in the study
Target sample size 35

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Makoto Ishitobi
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Breast and Endocrine Surgery
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL 0669721181
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Breast and Endocrine Surgery
Zip code
Address
TEL
Homepage URL
Email isitobi-ma@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 27 Day
Last modified on
2017 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005344

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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